NDLI: Pharmacokinetics of a fixed-dose combination of mitiglinide and metformin versus concurrent administration of individual formulations in healthy subjects: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover study.

Please wait, while we are loading the content...

Pharmacokinetics of a fixed-dose combination of mitiglinide and metformin versus concurrent administration of individual formulations in healthy subjects: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover study.

Pharmacokinetics and safety of ezetimibe/simvastatin combination tablet: an open-label, single-dose study in healthy Chinese subjects.

Medical service encounters and payments associated with topical adjunctive therapy use of timolol for glaucoma.

Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.

Year: 2012 Volume: 32 Issue: 11

Year: 2012 Volume: 32 Issue: 10

Year: 2012 Volume: 32 Issue: 9

Year: 2012 Volume: 32 Issue: 8

Year: 2012 Volume: 32 Issue: 7

Year: 2012 Volume: 32 Issue: 6

Year: 2012 Volume: 32 Issue: 5

Year: 2012 Volume: 32 Issue: 4

Year: 2012 Volume: 32 Issue: 3

Year: 2012 Volume: 32 Issue: 2

Year: 2012 Volume: 32 Issue: Supplementary 2

Year: 2012 Volume: 32 Issue: 1

Year: 2012 Volume: 32 Issue: Supplementary 1

Year: 2011 Volume: 31

Year: 2010 Volume: 30

Year: 2009 Volume: 29

Year: 2008 Volume: 28

Year: 2007 Volume: 27

Year: 2003 Volume: 23

Year: 2002 Volume: 22

Year: 2001 Volume: 21

Year: 2000 Volume: 20

Year: 1997 Volume: 13

Year: 1996 Volume: 12

Year: 1995 Volume: 10

Pharmacokinetics of a fixed-dose combination of mitiglinide and metformin versus concurrent administration of individual formulations in healthy subjects: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Jung, Jin Ah Kim, Jung-Ryul Kim, Suk-Ran Kim, Tae-Eun Lee, Soo-Youn Ko, Jae-Wook Huh, Wooseong
Spatial Coverage	Republic of Korea
Description	Author Affiliation: Jung JA ( Department of Clinical Pharmacology and Therapeutic, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-Gu, Seoul, Korea.)
Abstract	BACKGROUND: In the treatment of diabetes mellitus, combined drugs with different mechanisms of action can be effective when adequate glycaemic control is difficult with monotherapy. A fixed-dose combination (FDC) tablet of mitiglinide and metformin has been developed as a second-line treatment for type 2 diabetes. OBJECTIVES: The objective of this study was to compare the pharmacokinetics and safety of a FDC and a free combination of mitiglinide and metformin in healthy male subjects. METHODS: A randomized, open-label, two-period, two-treatment, single-dose, crossover study was conducted in 24 healthy Korean male subjects. In one period, a FDC tablet of mitiglinide and metformin (10 mg/500 mg) was administered, and in the other period, corresponding doses of individual formulations were administered. RESULTS: Twenty-four subjects were enrolled and 19 subjects completed the study. The geometric mean ratios (90 % confidence interval) of the maximum plasma concentration (C(max)) and area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC(last)) were 0.9694 (0.8120, 1.1573) and 0.8951 (0.8440, 0.9494) for mitiglinide, and 1.0235 (0.9373, 1.1057) and 1.0542 (0.9697, 1.1460) for metformin, which were within the bioequivalence range. Among the 23 subjects who received study drugs, 15 subjects experienced 34 adverse events (AEs). The most frequently reported AEs were feeling hot and compensatory sweating. There were no serious AEs and no significant differences in the incidence of AEs between the two treatments. CONCLUSION: A FDC tablet of mitiglinide and metformin was generally well tolerated in healthy male subjects. Administration of a FDC tablet and concomitant administration of individual formulations did not show significantly different pharmacokinetic profiles.
File Format	HTM / HTML
ISSN	11732563
Issue Number	12
Volume Number	32
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2012-12-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Hypoglycemic Agents Pharmacokinetics Isoindoles Metformin Adult Area Under Curve Cross-over Studies Drug Combinations Humans Administration & Dosage Adverse Effects Male Republic Of Korea Tablets Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Comparison of the bioavailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers.

Relative bioavailability and tolerability of two formulations of bicalutamide 50-mg tablets: a randomized-sequence, open-label, two-period crossover study in healthy Korean male subjects.

Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study.

Pharmacokinetics of a fixed-dose combination of atorvastatin and metformin extended release versus concurrent administration of individual formulations: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study.

Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects.

Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects.

Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers.

Comparative bioavailability and pharmacokinetics of investigational enteric- and film-coated formulations of flurbiprofen 100-mg tablets: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy Pakistani male volunteers.

Pharmacokinetics of a fixed-dose combination of mitiglinide and metformin versus concurrent administration of individual formulations in healthy subjects: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover study.

Similar Documents

Comparison of the bioavailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers.

Relative bioavailability and tolerability of two formulations of bicalutamide 50-mg tablets: a randomized-sequence, open-label, two-period crossover study in healthy Korean male subjects.

Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study.

Pharmacokinetics of a fixed-dose combination of atorvastatin and metformin extended release versus concurrent administration of individual formulations: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study.

Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects.

Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects.

Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers.

Comparative bioavailability and pharmacokinetics of investigational enteric- and film-coated formulations of flurbiprofen 100-mg tablets: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy Pakistani male volunteers.

Pharmacokinetics of a fixed-dose combination of mitiglinide and metformin versus concurrent administration of individual formulations in healthy subjects: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover study.